Use of the Leva Incontinence System in Treating Bladder Incontinence.

Renovia

Status

Completed

Conditions

Stress Urinary Incontinence

Treatments

Device: Leva Incontinence System For Pelvic Floor Muscle strengthening

Study type

Interventional

Funder types

Industry

Identifiers

NCT03536923

REN-01

Details and patient eligibility

About

This open-label proof-of-concept study is designed to evaluate the impact of the leva digital incontinence system on the treatment of stress and mixed urinary incontinence in women over a six week period. Subjects will participate in a 2.5 minute exercise program twice daily (performed at a clinic with therapist assistance 5x weekly, and at home once daily on weekdays and twice daily on weekends. Validated surveys (UDI-6, IIQ-7 and PGI-I) will be used to evaluate symptom relief. A battery of pelvic floor muscle exercises will be performed weekly to evaluate progress in muscle strengthening.

Enrollment

23 patients

Sex

Female

Ages

18 to 89 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Subjects must be female.
Subjects must be capable of giving informed consent.
Subjects should be at least 18 years of age and less than 89 years of age
Subjects must have a diagnosis of or symptoms of predominant mild to moderate urinary incontinence based on the results of the completed urinary incontinence surveys.

Exclusion Criteria:

Absence of a vagina.
Positive drug or alcohol test at the screening visit.
Post-menopausal defined as absence of a period for over 12 months.
Pregnancy or being less than 12 months post-partum.
Greater than three vaginal deliveries or prior operative delivery (e.g. use of vacuum, forceps or abdominal pressure).
Symptoms of stage II or greater pelvic organ prolapse.
BMI >31 kg/m2.
Diagnosis of any neurological disorder.
Prior lower back or pelvic surgery, including prior surgery for stress urinary incontinence (SUI).
Prior pelvic radiation.
Current or recurrent vaginal infections (>three per year).
Painful bladder syndrome, active or chronic pelvic pain.
Concurrent Pelvic Floor Muscle Exercises (PFME) under a supervised therapeutic plan of care.
Previous supervised pelvic floor muscles rehabilitation in the past 12 months for the treatment for urinary incontinence or any other pelvic floor disorder.
Currently taking medication to treat incontinence.
Impaired cognitive function.
Unable to tolerate use of the leva device.